← Back to catalogue
Sterile gauze swabs / balls
EUDAMEDClass I (EU MDR)
Ref 15-004Model (2.5-15cm)x(5-45cm)- 4/6/8/9/12/15/16/24/32/48/64ply Rectangular shape: 1~20 cm×2 ~100 cm- 1~64 ply Ball-shaped: ф 2.5 cm, ф 3 cm, ф 4 cm, ф 5 cm
Identity
- Trade Name
- Sterile gauze swabs / balls EUDAMED
- Device Name
- Sterile gauze swabs / balls EUDAMED
- Model / Reference
- (2.5-15cm)x(5-45cm)- 4/6/8/9/12/15/16/24/32/48/64ply Rectangular shape: 1~20 cm×2 ~100 cm- 1~64 ply Ball-shaped: ф 2.5 cm, ф 3 cm, ф 4 cm, ф 5 cm EUDAMED15-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960999 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSGS00167 EUDAMED
- Direct Marketing DI
- 06972013960999 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile gauze swabs / balls by Multigate Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697201396MU01SNNNSGS00167 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 8705bf98-349e-4bdc-8d4f-efa100b3fc5b 61 fields · synced Jun 19, 2026
- EUDAMED 11ecaaac-2edc-4c33-b08e-567544c0811c 61 fields · synced Jun 19, 2026